Shortening Drug Discovery Timelines
Current Challenges in Drug Discovery
Extended development timelines and rising costs
On average, it takes approximately ten years for a new drug to reach the market. Development costs have continued to rise over time, particularly during the early phases leading up to Investigational New Drug (IND) submission, where cost increases of 20–30% have been observed in recent years.
These prolonged timelines and escalating costs are driven by multiple factors.
Among them, the increasing volume and complexity of data, as well as growing interest in complex therapeutic modalities such as cell therapies and radiopharmaceuticals, have added significant complexity to the transition from preclinical to early clinical development.
As a result, there is an urgent need for initiatives that enable more efficient and streamlined research and development processes.
Three Strategic Levers to Accelerate Drug Development
To overcome these challenges and advance development more efficiently, biopharmaceutical companies are reassessing their R&D processes from three key perspectives:
Speed: Reducing the time to First-in-Human (FIH) studies to accelerate overall development timelines.
Cost: Optimizing early-stage investment to maximize return on R&D spending.
Output / Capacity: Improving the transition from discovery to development through advanced technologies and collaboration with external partners.
Impact of Shortening Non-Clinical Development Timelines
The non-clinical development phase represents one of the greatest opportunities for reducing overall R&D cycle time.
By implementing appropriate optimization strategies, development timelines traditionally spanning 21–26 months can be shortened to approximately 12–15 months, representing a reduction of more than 40%.
This impact has been demonstrated across both small-molecule programs and biologics. Early acceleration of non-clinical development significantly improves risk-adjusted net present value (NPV) and contributes to faster market entry for innovative therapeutics.
The Value of Accelerating Time to First-in-Human (FIH)
Reducing the time from candidate selection to First-in-Human studies directly enhances competitive advantage and allows more effective utilization of patent lifecycles. It also contributes to increased risk-adjusted NPV.
In practice, cases have been reported in which research and early development cycle times were reduced by up to 40%. Optimizing the early stages of the non-clinical process is therefore a critical strategy for delivering innovative therapies to patients more rapidly.
Approaches to Shortening Non-Clinical Development
Accelerating development timelines requires not only faster execution, but also structural optimization of development processes. Key approaches include the following:
Early investment and parallel execution
Audited draft reports generated during GLP toxicology studies can be leveraged at an early stage to initiate IND preparation in parallel. This approach helps avoid the 5–10 week delays that commonly occur during regulatory submission processes.
Simplification of experimental design
In early pharmacology studies, non-essential endpoints and cell lines can be reduced, allowing teams to focus on critical data and eliminate unnecessary experimental complexity.
Alternatives to in vivo studies
Replacing portions of early screening and safety assessment within silico models or high-fidelity in vitro systems can reduce the number and duration of animal studies while maintaining decision-quality data.
[PR] Supporting Productivity and Success with the STAM™ Model
Strategic use of external CRO resources
Collaboration with specialized contract research organizations (CROs) plays a vital role in enhancing research productivity and development efficiency. This is particularly important in disease areas where established clinical models are limited, and high-quality preclinical evidence is essential for informed decision-making.
Contribution of the STAM™ model to human-relevant disease modeling
The STAM™ mouse model provided by SMC Laboratories enables highly human-relevant modeling of disease progression in MASH (NASH) and hepatocellular carcinoma (HCC). By accurately reproducing disease development within a relatively short timeframe, the model supports robust evaluation of therapeutic efficacy.
Development Examples Using the STAM™ Model
Efficacy evaluation in liver cirrhosis using the STAM™ model
Using the STAM™ model, the antifibrotic effects of a candidate compound were evaluated at advanced stages of liver fibrosis.
The use of a model that closely reproduces human pathological changes enabled the generation of highly reliable data and supported decision-making for progression to clinical trials.
Advancing NASH drug development at fibrotic stages
In the development of therapeutics for NASH (MASH), detailed analysis of drug effects at specific fibrosis stages enabled the identification of clear biomarkers related to inflammation and fibrosis.
This approach facilitated a deeper understanding of mechanism of action and supported faster development of optimized clinical strategies.
Accelerating Time to Market Through Operational Excellence
Operational excellence in drug discovery extends beyond simple efficiency improvements. It requires fostering innovation within organizations, digitizing research processes, and strategically integrating external collaborations such as the STAM™ model.
By balancing speed, cost, and output, biopharmaceutical companies can deliver high-quality medicines to patients faster than ever before.
Japanese
